The large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) of the investigational Janssen COVID-19 single-dose vaccine candidate is now fully enrolled with approximately 45,000 participants. Given the high incidence of COVID-19 among the general population in the countries where the trial is being conducted, this number of participants will be sufficient to generate the data needed to determine the efficacy and safety of the Company’s investigational COVID-19 vaccine candidate. Johnson & Johnson expresses its thanks to all participants, trial sites and health care professionals involved in the ENSEMBLE study.
Interim data from the ENSEMBLE trial is currently anticipated to be available by the end of January 2021. However, as this trial is dependent on disease events, the timing is approximate. If the data indicate the vaccine is safe and effective, the Company expects to submit an Emergency Use Authorization application to the U.S. Food and Drug Administration (FDA) in February. Other health regulatory applications around the world will be made in parallel.
Johnson & Johnson continues to develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles. The Company is committed to transparency and sharing information relating to the Phase 3 ENSEMBLE study.
ENSEMBLE was initiated in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) under Other Transaction Agreement HHSO100201700018C, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS.
A separate Phase 3 clinical trial of the investigational Janssen COVID-19 vaccine candidate to explore a two-dose regimen of Janssen’s vaccine candidate (ENSEMBLE 2) is ongoing.
For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus.
Notice to Investors Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.